ICH Q11 Development and Manufacture of Drug Substances
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ICH Q11 Development and Manufacture of Drug Substances is an ICH guideline that provides principles and expectations for the development and manufacturing of chemical and biotechnological drug substances within a quality-by-design framework.
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
ICH guideline
ⓘ
pharmaceutical quality guideline ⓘ |
| addresses |
control of starting materials
ⓘ
critical process parameters for drug substance manufacture ⓘ critical quality attributes of drug substances ⓘ design space for drug substance processes ⓘ lifecycle management of drug substance manufacturing processes ⓘ linkage of material attributes and process parameters to quality ⓘ risk management in drug substance development ⓘ selection of starting materials ⓘ |
| appliesTo |
biological drug substances
ⓘ
biotechnological drug substances ⓘ chemical drug substances ⓘ |
| basedOnConcept | quality by design ⓘ |
| concerns |
biotechnological/biological drug substances produced by cell culture or fermentation
ⓘ
small molecule drug substances ⓘ |
| documentType | harmonised tripartite guideline ⓘ |
| emphasizes |
linkage between development data and control strategy
ⓘ
systematic approach to development ⓘ use of prior knowledge and experimental data ⓘ |
| focusesOn |
development of drug substances
ⓘ
manufacture of drug substances ⓘ |
| fullTitle | ICH Harmonised Tripartite Guideline Q11: Development and Manufacture of Drug Substances NERFINISHED ⓘ |
| hasAbbreviation | ICH Q11 NERFINISHED ⓘ |
| includesGuidanceOn |
description of manufacturing process development
ⓘ
establishment of control strategy ⓘ information to be submitted in regulatory dossiers ⓘ process validation considerations for drug substances ⓘ scale-up and technology transfer considerations ⓘ |
| issuedBy | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use NERFINISHED ⓘ |
| language | English ⓘ |
| objective |
to facilitate more flexible regulatory approaches to drug substance manufacturing
ⓘ
to promote scientific understanding of drug substance processes ⓘ to support consistent product quality over the lifecycle ⓘ |
| providesPrinciplesFor |
control strategy development
ⓘ
drug substance development ⓘ drug substance manufacturing process design ⓘ |
| regulatoryRegion |
European Union
NERFINISHED
ⓘ
ICH regions NERFINISHED ⓘ Japan NERFINISHED ⓘ United States NERFINISHED ⓘ |
| relatedTo |
ICH Q10 Pharmaceutical Quality System
NERFINISHED
ⓘ
ICH Q8 Pharmaceutical Development NERFINISHED ⓘ ICH Q9 Quality Risk Management NERFINISHED ⓘ |
| supportsImplementationOf |
ICH Q8 concepts for drug substances
ⓘ
pharmaceutical quality system for drug substances ⓘ quality risk management in development ⓘ |
| usedBy |
pharmaceutical industry
ⓘ
regulatory authorities in ICH regions ⓘ |
Referenced by (2)
Full triples — surface form annotated when it differs from this entity's canonical label.
ICH Q8 Pharmaceutical Development
→
relatedTo
→
ICH Q11 Development and Manufacture of Drug Substances
ⓘ
ICH Q9 Quality Risk Management
→
supports
→
ICH Q11 Development and Manufacture of Drug Substances
ⓘ